CompletedNot Applicable

Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis

United States, Bulgaria, Switzerland738 participantsStarted 2024-12-30

Plain-language summary

In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500 symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both. Additionally, a minimum of 100 asymptomatic individuals will also be enrolled in the study. The cobas® BV/CV assay amplifies and detects the deoxyribonucleic acid (DNA) of pathogens associated with bacterial vaginosis (BV) and candida vaginitis (CV). The BV results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays, and the CV results will be compared with the PIS established with the use of culture plus MALDI-TOF (matrix-assisted laser desorption/ionization time-of-flight). The primary objective of the clinical performance study is to evaluate the performance (sensitivity and specificity) of cobas® BV/CV to determine the presence of BV and/or CV in the intended use patient population when being tested on cobas® 6800/8800 systems. The secondary objective is to evaluate the equivalency of cobas® BV/CV between the cobas® 5800 system and cobas® 6800/8800 systems.

Who can participate

Age range

14 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Inclusion Criteria for Symptomatic Participants: * Symptomatic participants with a clinical presentation consistent with vaginitis, vaginosis, or both; symptoms may include abnormal vaginal discharge, painful or frequent urination, vaginal itching or burning or irritation, painful or uncomfortable intercourse, and/or abnormal vaginal odor. * Participants aged 14 years or older who are willing and able to provide written, informed consent; for pediatric participants, written assent and parent/legal guardian consent, as applicable by the institutional review board/ethics committee (IRB/EC). Inclusion Criteria for Asymptomatic Participants: * Apparently healthy participants aged 14 years or older who are willing and able to provide written, informed consent; for pediatric participants, written assent and parent/legal guardian consent, as applicable by the IRB/EC. Exclusion Criteria: Exclusion Criteria for Symptomatic Participants: * Participants not meeting the above described inclusion criteria will be excluded from the study. * Use of any azole-containing antimicrobial (oral or vaginal) within the 7 days prior to study enrollment. * Prior enrollment in this study. * Use of any lubricants (eg, Replens, RepHresh) within 3 days prior to sample collection * Use of douches, vaginal deodorizers, or other intravaginal products within 3 days prior to sample collection. The use of tampons or pads during menses should not be considered exclusionary criteria. *…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Sensitivity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status

Timeframe: Day 1

Clinical Specificity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status

Timeframe: Day 1

Positive Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status

Timeframe: Day 1

Negative Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status

Timeframe: Day 1

Trial details

NCT IDNCT06975436

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Bacterial Vaginosis trials

Plain-language summary

Who can participate

Age range

14 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Clinical Sensitivity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status

Timeframe: Day 1

Clinical Specificity of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status

Timeframe: Day 1

Positive Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status

Timeframe: Day 1

Negative Predictive Value of the cobas® BV/CV Test on the cobas® 6800/8800 Systems for Detecting the Presence of BV and/or CV Compared with the Patient Infection Status

Timeframe: Day 1